Vir, Bluejay invigorate hepatitis D landscape with new data
New readouts of hepatitis D treatments are prompting optimism that the long-barren set of options for patients might have new options on the horizon. New data from midstage trials from Vir...
View ArticleBiogen, UCB detail response rates in Phase 3 lupus trial after surprising...
Biogen and UCB on Tuesday shared an expanded dataset for their Phase 3 lupus program, which they said two months ago succeeded in a pivotal trial. In the 321-patient study, dapirolizumab pegol achieved...
View ArticleJimini Health launches with $8M for AI-assisted therapy
Therapists can’t be around for their patients 24/7. One startup is betting AI can be the solution. When trained with clinical supervision and data from past sessions, Jimini Health thinks that its AI...
View ArticleIncyte ends enrollment in Phase 2 chronic hives trial due to preclinical...
Incyte’s $750 million buyout of Escient Pharmaceuticals is in a rough patch as a mid-stage chronic hives candidate was flagged with safety concerns and a separate itch drug failed to clear its ...
View ArticleMerck finally has subcutaneous Keytruda results, and it's going to regulators
A decade after Keytruda hit the market, Merck has now said a subcutaneous version of the immunotherapy passed a Phase 3. That means Merck will discuss the ...
View ArticleJupiter Bioventures raises $70M fund for 'super-early' science
They've got $70 million, two guys named Ned, and plans to go after early-stage science where other venture capital firms "would fear to tread." On Tuesday, Jupiter Bioventures revealed itself as a new...
View ArticlePharma’s global access efforts have stalled, new report finds
Efforts by the pharmaceutical industry to expand access to low- and middle-income countries need to be “vastly accelerated” and in some cases have fallen behind, according to a new report. The Access...
View ArticlePharma telehealth programs are catching on and raising questions
A new way of selling medications has landed pharmaceutical companies in lawmakers’ crosshairs. Earlier this year, Eli Lilly unveiled a service called LillyDirect to connect patients seeking its...
View ArticleBayer, Cytokinetics make a deal in Japan; Ex-Carmot CEO to run LB...
Plus, news about Spyre, Tongrui Biotech, ATB Therapeutics, Freya Biosciences, Intas and Xbrane: Bayer, Cytokinetics ink deal for heart drug in Japan: The German drugmaker is paying €50 million upfront,...
View Article#ACR24: Bristol Myers takes on autoimmune diseases with cell therapy; New...
Bristol Myers Squibb recently presented data for the first time from its clinical trial of a cell therapy for autoimmune diseases, which has quickly become one of the most crowded fields in biopharma....
View ArticleJ&J, Protagonist reveal two Phase 3 wins for oral IL-23 drug that's expected...
Johnson & Johnson and Protagonist Therapeutics announced two Phase 3 successes for their oral IL-23 drug, showcasing the first results out of an expansive pivotal trial program in plaque psoriasis....
View ArticleLilly’s oral lipid drug passes mid-stage test
Eli Lilly reported positive data for its drug candidate for elevated lipids, marking a key milestone for a potential oral option in a space dominated by injectable candidates. Lilly’s muvalaplin met...
View ArticleBeiGene settles final suit over future Brukinsa generics
BeiGene has settled a lawsuit with generics manufacturer MSN Pharmaceuticals, resolving all cases associated with the entry of Brukinsa alternatives in the US. The pharma said Tuesday that MSN agreed...
View ArticleChinese drugmaker receives FDA warning letter after management hindered...
The FDA handed Chinese pharmaceutical company Tianjin Darentang Jingwanhong Pharmaceutical a warning letter after it removed information from translated manufacturing records and refused to let agency...
View ArticleFDA raises safety questions on AstraZeneca's bleeding reversal agent
The FDA on Thursday will convene an advisory committee to discuss the safety and efficacy of AstraZeneca’s Andexxa, which won accelerated approval in 2018 to reverse the anticoagulation effects of...
View ArticleFDA rejects Astellas' effort to support longer use of Izervay
The FDA has denied Astellas’ attempt to bolster the label for its vision loss treatment Izervay with additional two-year data. Izervay, the centerpiece of Astellas’ $5.9 billion acquisition of Iveric...
View ArticleNICE has 'done all we can' to negotiate for Enhertu coverage
The UK's drug pricing body has affirmed its earlier decision not to recommend coverage of AstraZeneca and Daiichi Sankyo’s breast cancer treatment Enhertu. “As we’ve always made clear, the fastest and...
View ArticleGSK plots regulatory filings for PBC itch after positive Phase 3 readout
GSK’s linerixibat helped reduce itch in patients with a rare bile duct disease, meeting its primary endpoint in a late-stage trial. If approved, linerixibat would be the first drug on the US market to...
View ArticlePfizer partners with two more Flagship biotechs on obesity, cancer
Pfizer is enlisting another Flagship startup to help it create new obesity medicines. After June's ProFound Therapeutics tie-up, Pfizer will work with the incubator's Ampersand Biomedicines in the hunt...
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